Practice Guideline Briefs
Am Fam Physician. 2004 Nov 15;70(10):2021-2026.
Updated CDC Influenza Vaccination Recommendations
The Centers for Disease Control and Prevention (CDC) has updated its recommendations on who should be vaccinated against influenza this season because there is not enough influenza vaccine for everyone who may want it. The influenza vaccine should be given to protect people who are most likely to have serious health problems ifthey get influenza. These people should get the vaccine:
Children ages six to 23 months.
People who are 65 years and older.
People two years or older who have an underlying, long-term illness (e.g, heart disease, lung disease, metabolic disease, kidney disease), a blood disorder, or are immunocompromised.
Women who are or will be pregnant this influenza season.
People who live in nursing homes or chronic-care residencies.
People who are six months to 18 years of age and take aspirin daily.
Health care workers directly involved with patient care.
People who have or take care of an infant younger than six months of age.
Infants younger than six months of age should not receive the influenza vaccine.
Healthy people two to 64 years of age should wait to be vaccinated or skip getting a shot this season.
Healthy people ages five to 49 years of age may receive the nasal-spray vaccine. This is a good option for people in this age group who have or care for infants younger than six months of age or for health care workers who take care of sick patients. Pregnant women and people who care for or live with someone whose immune system is very weak should not use the nasal spray.
Additional information about the influenza vaccine is available online at www.cdc.gov.
Strategy to Strengthen Safeguards for Children Treated with Antidepressants
The U.S. Food and Drug Administration (FDA) has issued a public health advisory announcing a multi-pronged strategy to warn the public about the increased risk of suicidal thoughts and behavior (“suicidality”) in children and adolescents taking antidepressants. The advisory is available online at http://www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm.
The FDA is directing antidepressant manufacturers to add a “black box” warning to the health professional labeling of all antidepressants to describe this risk and emphasize the need for close monitoring of patients started on these medications.
This direction is based on a pooled analysis of 24 studies of antidepressants (selective serotonin reuptake inhibitors [SSRIs] and others) in more than 4,400 children and adolescents with major depression, obsessive-compulsive disorder, and other psychiatric disorders. These studies found a 4 percent risk of suicidal thinking or behavior in patients taking antidepressants compared with a 2 percent risk in patients taking placebo (number needed to treat for one to four months: 50).
The black box warning also notes what uses the anti-depressants have been approved or not approved for in these patients. The FDA also has addressed other labeling changes designed to include additional information about studies of these drugs in children. These labeling changes are applicable to the entire category of antidepressant medications because the currently available data are not adequate to exclude any single medication from the increased risk of suicidality.
Fluoxetine (Prozac) is the only medication approved to treat depression in children and adolescents. The analyses of the placebo-controlled trials in children and adolescents summarized in the revised labeling are based on studies of five SSRIs (citalopram [Celexa], fluvoxamine [Luvox], paroxetine [Paxil], fluoxetine, and sertraline [Zoloft]) and four “atypical” antidepressants (bupropion [Wellbutrin], mirtazapine [Remeron], nefazodone [Serzone], and venlafaxine [Effexor]). In these studies, there was no reported suicide.
A black box warning is the most serious warning placed in the labeling of a prescription medication. Advertisements that serve to remind health care professionals of a product’s availability (so-called “reminder ads”) are not allowed for products with black box warnings. The new warning language does not prohibit the use of antidepressants in children and adolescents. Rather, it warns of the risk of suicidality and encourages prescribers to balance this risk with clinical need.
The FDA recognizes that depression and other psychiatric disorders in children and adolescents can have significant consequences if not appropriately treated. The new warning language recognizes this need but advises close monitoring of patients as a way of managing the suicidality risk.
The FDA is developing a Patient Medication Guide which needs to be given by pharmacists to patients taking antidepressants to advise them of the suicidality risk and precautions that can be taken. In addition, the FDA intends to work with manufacturers to implement “Unit-of-Use” packaging for all antidepressants as a means of ensuring that patients receive a medication guide with every prescription or refill. Unit-of-use packaging is a method of preparing a medication in an original container, sealed and labeled by the manufacturer, and containing sufficient medication for one normal course of therapy.
Risk of Recurrent Stroke with Patent Foramen Ovale and Atrial Septal Aneurysm
The Quality Standards Subcommittee of the American Academy of Neurology has released a new guideline entitled, “Practice Parameter: Recurrent Stroke with Patent Foramen Ovale and Atrial Septal Aneurysm.” The guideline is available online at http://www.neurology.org/cgi/content/full/62/7/1042.
A patent foramen ovale (PFO) is a small opening between the two upper chambers of the heart, or the atria. The opening normally closes shortly after birth, but does not close in up to 25 percent of people. Current thinking is that patients with a PFO who have had a stroke with no known cause and received treatment are at greater risk of having a second stroke than those patients who had a stroke and did not have a PFO. However, this is not true according to the guideline. Having a PFO does not place the patient at increased risk for a recurrent stroke.
There has been some debate within the medical community about whether PFOs should be closed or managed with medication. According to the guideline, there is no evidence to support or refute the role of closing a PFO for stroke prevention. More research is needed to answer this question.
Persons younger than 55 years with both a PFO and an atrial septal aneurysm (ASA) may have an increased risk of a second stroke. An ASA is a bulge in the wall between the atria and occurs in an estimated 5 percent of people. Up to 70 percent of people with an ASA also have a PFO.
Both aspirin and warfarin reduce the risk of blood clots that can cause stroke. According to the guideline, there is inadequate evidence to determine whether aspirin or warfarin is the better medication to prevent subsequent stroke and death. However, the side effect of minor bleeding is more common with warfarin than aspirin.
The authors of the guideline call for more research on the effects of an ASA on stroke risk and how ASAs should be managed. They also encourage physicians to communicate with patients who have had a stroke and are on aspirin or warfarin therapies about their future health risks. Patients should know that the presence of a PFO does not necessarily signify an increased risk for subsequent stroke, however these patients should consider participating in research studies to further address this condition.
Norovirus Gastroenteritis Outbreak at a Swimming Club
John Snow’s historic investigation in London, England, of a severe epidemic of cholera traced the cause of infection to a common water source. Today, 150 years later, waterborne diseases remain a public health problem, and similar investigations are used to identify the source of infection. On February 3, 2004, the Vermont Department of Health (VDH) was notified of an outbreak of acute gastroenteritis among children whose only common exposure was attendance at a swimming club the previous weekend.
The VDH and the Centers for Disease Control and Prevention (CDC) determined the cause of the outbreak to be a combination of stool contamination, a blocked chlorine feed tube, and multiple lapses of pool-maintenance procedures.
Attendance records indicated that seven private groups used the pool, including three mother-infant swimming classes, two groups from a local girls’ organization, a birthday party of children five to 10 years of age, and a preschool class. In addition, members of the club used the pool during two defined open-swim sessions. Of the 189 persons for whom information was collected and who visited the pool during the outbreak period, 53 (28 percent) reported an illness consistent with the case definition of gastroenteritis. Among these 53 persons, onset of symptoms began a median of 30 hours after attending an event at the club and included vomiting, diarrhea, nausea, stomach cramps, chills, and a fever higher than 38°C (100.4°F).
No obvious source of contamination was identified: all infants were reported to have worn swim diapers while in the pool, no vomiting or fecal incidents were reported, and no persons, when questioned, reported gastrointestinal illness in the two weeks before visiting the pool. Interviews with swimmers and staff indicated that the water was visibly cloudy throughout the weekend, when the regular maintenance person was not on duty and pool usage was the highest. A kink in the tube that supplies chlorine to the pool was subsequently identified and repaired by the pool’s maintenance manager.
At the time of the review, although disinfection equipment was working properly and pool chlorine and pH levels, and temperature were consistent with recommended national standards, multiple lapses and inadequacies in pool management were identified. Of these, most remarkable were a lack of staff training and response policies, and the absence of records of the pool’s chemistry-monitoring results or pool maintenance.
Although waterborne outbreaks of norovirus gastroenteritis are much less commonly reported than foodborne outbreaks, the recorded incidence of norovirus-associated waterborne disease is likely an underestimate because of the lack of simple diagnostic technology. However, norovirus outbreaks associated with swimming pools rarely are reported.
Although prevention of norovirus outbreaks is difficult, this outbreak investigation suggests that staff training, pool-chemistry monitoring, and maintenance of appropriate disinfectant levels are important prevention strategies. As with John Snow’s Broad Street cholera outbreak (see accompanying box to the right), a series of environmental health failures occurred, creating conditions that could convey almost any waterborne pathogen.
Copyright © 2004 by the American Academy of Family Physicians.
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